NCT02493790

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) is a respiratory disease starting point characterized by multiple systemic effects as cognitive dysfunction. This one seems to have an impact in activity daily living, considered mainly as a cognitive-motor dual task situations. Yet to date, no study has specifically focused in the cognitive-motor performance in patients with COPD or on the effects during a rehabilitation program. The main objective of this work was to evaluate the impact of cognitive dysfunction in COPD, comparing performance between COPD patients and healthy subjects in a single and dual task cognitive-motor situation. The secondary objective was to assess the impact of a rehabilitation program on these performances.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 10, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

December 20, 2016

Status Verified

December 1, 2016

Enrollment Period

8 months

First QC Date

June 30, 2015

Last Update Submit

December 19, 2016

Conditions

Keywords

cognitive dysfunctionActivity of Daily Livinginterferencerehabilitationcognitive-motor dual task

Outcome Measures

Primary Outcomes (2)

  • Variability of Cognitive performances in a single and dual task situations

    Cognitive performance were determined by error count and number of substraction during a counting task.

    3 months

  • Variability of motor performances in a single and dual task situations

    Motor performance were determined by variability of length and surface of postural condition and by step variability in locomotion condition

    3 months

Secondary Outcomes (2)

  • Effect of rehabilitation program on Cognitive performances in a single and dual task

    3 months

  • Effect of rehabilitation program on motor performances in a single and dual task

    3 months

Study Arms (2)

Volunteers

Cognitive and motor performances were measured in a single and dual task situations.

Other: Cognitive and motor performances

COPD patients

Cognitive and motor performances were measured in a single and dual task situations, before rehabilitation, and compared to those of healthy subjects. Then, Chronic Obstructive Pulmonary Disease patients were re-evaluated after rehabilitation.

Other: Cognitive and motor performances

Interventions

COPD patientsVolunteers

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

COPD patients, entered in a rehabilitation program in Clinique du Souffle were included

You may qualify if:

  • Male or female about 40 to 80 years old
  • COPD patient (Tiffeneau \<70%); stage moderate to severe (Stage 2,3 and 4) with or without oxygen therapy (\>15h/day)
  • Written and informed consent of the subject
  • Authorization to physical activity referring doctor in the clinic
  • Comorbidities no dominating

You may not qualify if:

  • Subject with neurological pathology, cognitive or psychiatric
  • Subject with pain and / or plantar injuries
  • Subject has a prosthetic knee and / or hip.
  • Subject requiring walking aid (cane, walker, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveCognitive Dysfunction

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2015

First Posted

July 10, 2015

Study Start

October 1, 2014

Primary Completion

June 1, 2015

Study Completion

August 1, 2016

Last Updated

December 20, 2016

Record last verified: 2016-12